Regulatory Strategy Director, Oncology (Phase 1/2)

Repertoire-Immune-Medicines; Watertown (MA); Hybrid; USD 210,000 - 245,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Life insurance

Flexible time off

401(k) retirement plan

Incentive opportunities

Job summary

Repertoire Immune Medicines is seeking a Director of Regulatory Affairs to lead global regulatory strategy for its clinical-stage oncology programs. This hands-on role in Watertown, MA will own IND/CTA submissions, health authority interactions, and cross-functional alignment with Clinical Development, CMC, and Quality.

The ideal candidate has 10+ years in regulatory affairs with oncology drug development, strong FDA experience, and EU/UK submission expertise.

Qualifications

• Over 10 years in Regulatory Affairs within biotech/pharma with proven leadership.
• Experience leading Phase 1/2 oncology regulatory programs and submissions.
• Direct interactions with FDA; strong EU CTIS and UK/MHRA exposure.

Responsibilities

• Develop and execute global regulatory strategy for Phase 1/2 oncology programs.
• Lead submissions (INDs, CTAs, amendments) and health authority interactions.
• Provide strategic guidance on early clinical development and expedited pathways.
• Collaborate with Clinical Development, CMC, Quality to integrate regulatory plans.
• Mentor external consultants and build in-house regulatory capability.
• Monitor evolving regulations in U.S., EU, and UK and adjust programs.

Skills

Regulatory strategy

Health authority interactions

Cross-functional leadership

FDA interactions

EU/UK regulatory submissions

Clinical development knowledge

Regulatory consulting management

Clear communication

Job description

Repertoire Immune Medicines is seeking a Director of Regulatory Affairs to lead global regulatory strategy for its clinical-stage oncology programs. This hands-on role in Watertown, MA will own IND/CTA submissions, health authority interactions, and cross-functional alignment with Clinical Development, CMC, and Quality.

The ideal candidate has 10+ years in regulatory affairs with oncology drug development, strong FDA experience, and EU/UK submission expertise.